Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Industrialized nations could benefit from strategies emerging in developing nations such as respectful collaboration between traditional out-of-hospital birthing practices and maternity units in partnering hospitals.
The physician must consider the potential benefits of the new procedure and then determine, through discussion with the patient, what value the patient places on those specific benefits.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015; 17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.